Prognostic Value of Continuous Intra-abdominal Pressure (CIAP) and Continuous Abdominal Perfusion Pressure (CAPP) Monitoring for Acute Kidney Injury (AKI) Prediuction in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Incidence of acute kidney injury (AKI) in participants with and without intra-abdominal hypertension (IAH)
研究概览
简要总结
The goal of this observational study is to learn whether high abdominal pressure or low blood flow pressure to the kidneys is linked to kidney injury after heart surgery. The main questions it aims to answer are:
Does high abdominal pressure increase the risk of kidney injury after cardiac surgery?
Can low blood flow pressure to the kidneys help predict who may develop kidney problems?
Participants in this study are adults undergoing heart surgery, such as coronary artery bypass grafting (CABG) or valve surgery. Researchers will measure abdominal pressure and blood pressure continuously before and after surgery using medical devices that are already part of routine care. This study does not involve any changes to standard treatment.
Participants will:
Have their abdominal and blood pressures continuously monitored using existing devices
Have blood and urine tests to check kidney function
Be followed during their hospital stay and up to 30 days after surgery to assess outcomes like length of stay, readmission, and survival
This study takes place at two hospitals-one in Poland and one in the United States. Researchers hope the findings will help identify early warning signs of kidney injury and improve monitoring practices after heart surgery.
详细描述
This is a prospective, observational pilot study designed to investigate the relationship between elevated intra-abdominal pressure (IAP), impaired perfusion pressures, and the development of acute kidney injury (AKI) in adult patients undergoing cardiac surgery. The study will focus on whether continuous intra-abdominal pressure (CIAP) monitoring can provide early warning signs for AKI and other postoperative complications.
Intra-abdominal pressure (IAP) refers to the steady-state pressure within the abdominal cavity. In healthy individuals, IAP typically ranges between 5 and 7 millimeters of mercury (mmHg), while values may rise to around 10 mmHg in critically ill patients. Sustained IAP values at or above 12 mmHg define intra-abdominal hypertension (IAH). More severe elevations above 20 mmHg can result in abdominal compartment syndrome (ACS), which is associated with new organ dysfunction or failure. IAH can negatively impact multiple organ systems, including the kidneys, lungs, cardiovascular system, gastrointestinal tract, liver, and brain, through both mechanical and biochemical mechanisms.
Traditional IAP monitoring methods rely on intermittent measurement via the urinary bladder using a Foley catheter and saline instillation, performed at end-expiration with the patient in the supine position. Although this method is widely accepted, it is labor-intensive, operator-dependent, and cannot provide real-time pressure trends. As a result, diagnosis and management of IAH may be delayed.
Advancements in monitoring technology now allow for continuous IAP measurement using devices such as the TraumaGuard catheter. This dual-balloon Foley catheter provides real-time data on both IAP and core body temperature. It connects to standard intensive care unit (ICU) bedside monitors and allows continuous data capture and analysis.
This study will use continuous measurements of IAP, mean arterial pressure (MAP), central venous pressure (CVP), and mean alveolar pressure (Palv) to calculate key perfusion pressures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of acute kidney injury (AKI) in participants with and without intra-abdominal hypertension (IAH)
时间窗: Postoperative Days 0 through 7
To determine whether the presence of intra-abdominal hypertension (IAP ≥ 12 mmHg) is associated with a higher incidence of AKI follow. Measure Type: Binary outcome. Unit of Measure: % of participants with AKI. Method of Assessment: AKI will be diagnosed using the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, based on changes in serum creatinine and urine output. IAH will be defined as intra-abdominal pressure (IAP) ≥ 12 mmHg, measured using continuous intra-abdominal pressure monitoring.
次要结局
- Association between mean perfusion pressure (MPP) and incidence of acute kidney injury (AKI)(Postoperative Days 0 through 7)
- Association between intra-abdominal hypertension (IAH) and postoperative myocardial injury(Postoperative Days 0 through 7)
- Agreement between intra-abdominal pressure (IAP) measurements using the TraumaGuard device and standard intermittent bladder pressure measurements(Up to 48 hours post-surgery (duration of Foley catheter placement in ICU))
- Association between abdominal perfusion pressure (APP) and incidence of acute kidney injury (AKI)(Postoperative Days 0 through 7)
- Association between renal perfusion pressure (RPP) and incidence of acute kidney injury (AKI)(Postoperative Days 0 through 7)
研究者
Manu Malbrain
Professor Critical Care Research, First Department of Anaesthesiology and Intensive Therapy
Medical University of Lublin